brassica vegetables or indole-3-carbinol in treating patients with psa recurrence after surgery for prostate cancer

Conditions: Prostate Cancer

Summary: rationale: eating a diet high in vegetables may lower the risk of some types of cancer. brassica vegetables (such as cabbages, kale, broccoli, brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence. purpose: this randomized clinical trial is studying the side effects and how well brassica vegetables work compared with indole-3-carbinol in treating patients with psa recurrence after surgery for prostate cancer.

objectives: * determine the feasibility of brassica vegetable intake and indole-3-carbinol supplement use in patients with prostate cancer with prostate-specific antigen (psa) recurrence after prostatectomy. * identify adverse events in these patients. * quantify the effects of each intervention on psa in these patients. outline: patients are stratified by pretreatment prostat-specific antigen (psa) growth rate (low \[0.00-0.15\] vs medium \[0.16-0.30\] vs high \[\> 0.30\]). they are randomized to 1 of 3 treatment arms, and randomization status to arms ii and iii is double-blinded. * arm i (brassica vegetables): patients consume brassica vegetables at least 2 servings (½ cup/serving) daily for 6 months. patients meet one-on-one with the study dietician, and are instructed on the potential health benefits of brassica vegetables and purchase and preparation of the vegetables. patients undergo telephone counseling periodically in months 1-5, to monitor their progress and identify barriers to adherence and to develop solutions to overcome these barriers. * arm ii (placebo): patients receive oral placebo once daily for 6 months. * arm iii (indole-3-carbinol supplement): patients receive oral indole-3-carbinol supplement (capsules) once daily for 6 months. blood and urine samples (for urinary isothiocyanate levels) are collected at baseline and at 2, 4, and 6 months. patients complete questionnaires assessing demographics, family cancer history, and health history and measuring changes in medications, lifestyle, adverse events, and health. medical records are reviewed for prostate cancer-related information, surgical dates, dose and type of radiation, and psa history.

Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer with psa recurrence after prostatectomy * psa recurrence is defined as two consecutively rising psa tests ≥ 8 weeks since the post-surgical nadir, with a minimal interval of 2 weeks between tests and at least 1 psa test \> 0.4 ng/ml exclusion criteria: * life expectancy ≥ 9 months * no predictors of poor adherence (e.g., erratic life-style, mental incompetence) prior concurrent therapy: * see disease characteristics * no other concurrent brassica vegetable consumption \> 1 serving/day * no other concurrent indole-3-carbinol supplements * no endocrine or radiation treatment within past 4 weeks * no other scheduled treatment during study intervention * concurrent prescription medications during the trial allowed * at least 2 weeks since prior and no concurrent vitamin or herbal supplement use * patients refusing to stop non-study supplements will be asked to maintain constant use

Keywords: recurrent prostate cancer